The Food and Drug Administration (FDA) has rejected Amarin Corp’s preset testing process that is critical to the company’s plan in seeking a wider usage for its cholesterol-lowering drug Vascepa.
Vascepa is a prescription-strength fish-oil pill designed to lower triglyceride levels in patients with high cholesterol. The drug was approved in 2012 for a very small and specific use in patients with unusually high triglycerides. Amarin was hoping to expand usage of the drug to include patients at high risk of coronary heart disease who are also taking statin medications.
The first line of defense for treating high cholesterol beyond a more structured diet is statin drugs, such as the widely prescribed Lipitor. Statins can increase blood sugar levels and put users at risk for type 2 diabetes. The side effects of statins often make them intolerable to some patients.
An FDA advisory panel voted earlier this year not to recommend expanding the indication, citing no proof that Vascepa helped reduce heart attack risk. The advisory panel recommended that Amarin first complete a study on heart attack rates in patients who used the drug.
The FDA is not required to follow the recommendation of its advisory panels, but it usually does. However, last month when faced with making a formal ruling on expanding the indication of Vascepa, the FDA delayed its decision based on questions regarding the design of research. Amarin appealed to the FDA to reinstate a special protocol assessment but ultimately it was not enough to win the agency’s approval.